DSP-3025 A Phase 1 Study of Healthy Male Volunteers

A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Repeated Weekly Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01124396

Enrollment

Registered

2010-05-17

Start date

2010-04-30

Completion date

2012-04-30

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers

Interventions

DRUGDSP-3025

DRUGPlacebo

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to 39 Years

Healthy volunteers

Yes

Inclusion criteria

* Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg * No clinically relevant abnormal findings

Exclusion criteria

* Acute illness which requires medical intervention * Definite or suspected personal history of adverse drug reactions or drug hypersensitivity * Clinical relevant disease or disorder (past or present) * A history of respiratory disorder(s) such as asthma

Design outcomes

Primary

Measure	Time frame
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry	During the study

Secondary

Measure	Time frame
Clinical chemistry, haematology, urinalysis, autoantibodies	During the study
Nasal symptoms and peak nasal inspiratory flow	During the study
Pharmacokinetics	During the study
Biomarkers nasal lavage and blood	During the study

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026